Eisai Inc. Receives Complete Response Letter From The U.S. Food And Drug Administration For Dacogen® (decitabine) For Injection SNDA In Acute Myeloid Leukemia
Because there are no data on use of DACOGEN in patients with renal or hepatic dysfunction, DACOGEN should be used with caution in these patients.
For DACOGEN full prescribing information, please click here.
About Astex Pharmaceuticals
Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals developed Dacogen® (decitabine) for Injection and receives significant royalties on global sales.For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com. Forward-Looking Statements This press release contains “forward-looking” statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created thereby. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These forward-looking statements include, but are not limited to, statements regarding the expected timing of EMA approval of a new indication for Dacogen. Important additional factors that could cause actual results to differ materially from the expectations reflected in the forward-looking statements include, but are not limited to: risks and uncertainties related to the regulatory decision of the EMA and whether Dacogen will achieve approval for any additional patient indications. In general, our future success is dependent upon numerous factors, including our ability to generate pre-clinical development candidates for selection into clinical testing, obtaining regulatory approval of product development programs, conducting and completing clinical trials, obtaining regulatory approval of our products and product candidates, creating opportunities for future commercialization of compounds, and accurately assessing and disclosing the risks associated with Dacogen and other drugs we develop. References made to the discussion of risk factors are detailed in the Company’s filings with the Securities and Exchange Commission (the “SEC”) including reports on its most recently filed Form 10-K and Form 10-Q. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward-looking statements, whether as a result of new information, future events or otherwise.
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